Marvelon

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Marvelon
0.15 mg + 0.03 mg, tablets
Desogestrel + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If in doubt, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are similar.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Marvelon is and what it is used for
2. Important information before taking Marvelon
       2.1 When not to take Marvelon
       2.2 When to exercise special caution with Marvelon
       2.3 When to consult a doctor
3. How to take Marvelon
       3.1 When and how to take the tablets
       3.2 Starting the first pack of Marvelon
       3.3 Taking more Marvelon than recommended
       3.4 What to do if...
       3.5 Stopping Marvelon
4. Possible side effects
5. How to store Marvelon
6. Contents of the pack and other information
       6.1 What Marvelon contains
       6.2 What Marvelon looks like and contents of the pack
       6.3 Other information

1. What Marvelon is and what it is used for

Marvelon is a combined oral contraceptive. Each tablet contains a small dose of two different female hormones: desogestrel (a progestogen) and ethinylestradiol (an oestrogen). Because of its low hormone content, Marvelon is known as a low-dose contraceptive pill. Marvelon belongs to the group of monophasic combined oral contraceptives, as all tablets in the pack contain the same amount of hormones.
Marvelon is used to prevent pregnancy.
The oral contraceptive method is a highly effective method of birth control. The chance of becoming pregnant while taking contraceptive tablets (provided the patient does not miss any tablets) is very small.

2. Important information before using Marvelon

General remarks
Before starting to take Marvelon, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2, "Blood clots").
This leaflet describes most situations when you should stop taking the tablet or when its effectiveness may be reduced. During such situations, you should abstain from sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or another mechanical method. Do not use the rhythm method or temperature measurement method. These methods may be ineffective because contraceptive pills cause changes in body temperature and cervical mucus that occur during the menstrual cycle.
Marvelon, like other contraceptive pills, does not protect against HIV infection (AIDS)
or other sexually transmitted diseases.
Marvelon is prescribed individually by a doctor for each woman. Do not give Marvelon to other people.
Marvelon should not be used to delay the onset of menstrual bleeding.
In exceptional cases, when there is a need to delay the start of bleeding, consult your doctor.

2.1 When not to use Marvelon
Do not use Marvelon if any of the following conditions apply to you. If any of the conditions listed below apply to you, inform your doctor. Your doctor will discuss with you which other method of contraception might be more suitable.

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia
• if you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) pancreatitis associated with severe hypertriglyceridemia;
• if you have jaundice or severe liver disease;
• if you currently have or have previously had a malignant hormone-dependent tumour (e.g. of the breast or reproductive organs);
• if you currently have or have previously had a benign or malignant liver tumour;
• if you have vaginal bleeding of unknown cause;
• if you have endometrial hyperplasia (abnormal thickening of the uterine lining);
• if you are or may be pregnant;
• if you have hepatitis C virus infection and are taking medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir or glecaprevir, pibrentasvir (see also section "Marvelon with other medicines").

If any of the above conditions occur for the first time while taking Marvelon, you should stop taking the medicine and consult your doctor, using a non-hormonal method of contraception in the meantime (see also section 2, "General remarks").

2.2 When to exercise special caution when using Marvelon
Before starting to take Marvelon, discuss this with your doctor or pharmacist.
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below, "Blood clots"). For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
If these symptoms appear or worsen during treatment with Marvelon, inform your doctor as well.

• if you smoke;
• if you have diabetes;
• if you are obese;
• if you have high blood pressure;
• if you have heart valve disorders or heart rhythm disturbances;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if thromboembolic disease, heart attack, or stroke occurs in close family members;
• if you have migraine;
• if you have epilepsy;
• if you have elevated blood fat levels (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a long time (see section 2, "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor about how soon after delivery you can start taking Marvelon;
• if breast cancer is currently present or has occurred in close family members;
• if you have liver or gallbladder disease;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the natural immune system);
• if you have hemolytic uremic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if conditions such as hearing loss, porphyria, herpes gestationis, or Sydenham's chorea occurred for the first time or worsened during pregnancy or previous use of hormonal contraception;
• if you develop symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with possible breathing difficulties – seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you currently have or have previously had chloasma (yellowish-brown skin pigmentation, especially on the face); in such cases, avoid exposure to sunlight or ultraviolet radiation.

If any of the above factors occur for the first time, recur, or worsen during treatment with the tablets, contact your doctor immediately.

2.2.1 Hormonal contraception and thromboembolic disorders
BLOOD CLOTS
Using combined hormonal contraceptives, such as Marvelon, increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with the use of Marvelon is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, deep vein thrombosis, especially if accompanied by:

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.

• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.

• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.

• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or another product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Marvelon, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots in veins depend on?
The risk depends on the individual's natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive being used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Marvelon is low.

• In a year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing desogestrel, such as Marvelon, will develop blood clots.
• The risk of developing blood clots in veins depends on the individual's medical history (see "Factors increasing the risk of venous blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Marvelon is small, however
some factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);

• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs or other organs at a young age (e.g. below 50 years of age). In this case, the patient may have an inherited clotting disorder;

• if the patient requires surgery, is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Marvelon
  a few weeks before surgery or immobilisation. If the patient must
  discontinue Marvelon, ask the doctor when it is safe to resume taking
  the medicine;

• with increasing age (particularly above 35 years of age);

• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in
the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Marvelon.
Inform the doctor if any of the above conditions change during treatment with Marvelon, e.g. if a close family member is diagnosed with thrombosis of unknown cause or if the patient gains significant weight.
ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial blood clots can cause serious
consequences, such as heart attack or stroke.
Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Marvelon is very small, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Marvelon, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (below 50 years of age). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions, or if any of them is particularly severe, the risk of blood clots may be further increased.

Inform the doctor if any of the above conditions change during treatment with Marvelon, e.g. if the patient starts smoking, if a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.
2.2.2 Hormonal contraception and cancer
Breast cancer occurs slightly more frequently in women using contraceptive pills than in women of the same age who do not use them. This slight increase in breast cancer diagnosis gradually disappears within 10 years after stopping contraceptive pills. It is unknown whether this difference is caused by the use of contraceptive pills. It may be related to the fact that women using pills undergo more frequent medical examinations and thus breast cancer is diagnosed earlier.
Very rarely, benign liver tumours have been observed in women using contraceptive pills, and even more rarely, malignant ones. Such tumours may lead to intra-abdominal bleeding. In case of severe abdominal pain, contact a doctor immediately.
Chronic infection with human papillomavirus (HPV) is the most significant risk factor for cervical cancer. Cervical cancer may occur slightly more frequently in women who use contraceptive pills for a long time. This may not be caused by contraceptive pills. It is probably related to sexual behaviour or other factors.
Psychiatric disorders
Some women using hormonal contraceptives, including Marvelon, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.
2.2.3 Interaction of Marvelon with other medicines
Always inform the doctor about any medicines or herbal products currently used by the patient. Also inform any other specialist doctor, dentist or pharmacist prescribing other medicines about the use of Marvelon. They may advise on the need for additional contraceptive methods (e.g. condoms), how long they should be used, and whether adjustment of another medicine is required.
Some medicines

• may affect the blood concentration of Marvelon
• may reduce its contraceptive effectiveness
• may cause unexpected bleeding

This applies to medicines used in the treatment of:

• epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin, rifabutin);
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g. boceprevir, telaprevir);
• other infectious diseases (e.g. griseofulvin);
• high blood pressure in the pulmonary blood vessels (bosentan);
• depressive disorders (St. John's wort ( Hypericum perforatum )).

If the patient is taking medicines or herbal remedies that may reduce the effectiveness of Marvelon, a mechanical contraceptive method should also be used. Since the effect of another medicine on Marvelon may persist for up to 28 days after stopping the medicine, additional mechanical contraception is required during this period.
Marvelon may affect the action of other medicines such as, for example

• medicines containing cyclosporine
• the antiepileptic drug lamotrigine (this may lead to increased frequency of seizures)

If the patient has hepatitis C virus infection and is taking medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir or glecaprevir, pibrentasvir, Marvelon should not be used, as this may cause increased liver function parameters in blood laboratory tests (increased activity of the liver enzyme AlAT).
Before starting these medicines, the treating doctor will prescribe another type of contraceptive.
Marvelon may be restarted approximately 2 weeks after completion of this treatment. See section "When not to use Marvelon".
2.2.4 Pregnancy and breast-feeding
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Marvelon is contraindicated during pregnancy.
If pregnancy is suspected during treatment with Marvelon, contact a doctor immediately.
Use of Marvelon is not recommended during breast-feeding.
If the patient wishes to use Marvelon during breast-feeding, she should consult a doctor.
2.2.5 Driving and operating machinery
The use of Marvelon has no effect on the ability to drive or operate machinery.
2.2.6 Marvelon contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, she should contact her doctor before taking the medicine.
2.2.7 Use in children and adolescents
There are no available clinical data on efficacy and safety of use in children and adolescents under 18 years of age.
2.3 When to consult a doctor
Regular check-ups
The patient using contraceptive pills should be informed by the doctor about the need for regular medical examinations. Such examinations are usually performed once a year.
Contact a doctor immediately in the following cases:

• if the patient notices symptoms suggesting blood clots, which may indicate deep vein thrombosis in the leg, pulmonary embolism, heart attack or stroke (see section above "BLOOD CLOTS"). For a description of symptoms of these serious adverse reactions, see "How to recognize the occurrence of blood clots".

• if any changes in health occur, especially the conditions mentioned earlier in the leaflet (see sections "When not to use Marvelon" and "Important information before
  using Marvelon"), including information about the health status of close family members that may affect the use of contraceptive pills;

• detection of a breast lump;

• if the patient develops symptoms of angioedema, e.g. swelling of the face, tongue and (or) throat, and (or) difficulty swallowing, or urticaria with potential breathing difficulties (see also section 2.2 When to exercise particular caution when using Marvelon);

• intention to use other medicines (see also section 2.2.3 "Interaction of Marvelon with other medicines");

• immobilisation or planned surgical procedure (consult a doctor at least 4 weeks in advance);

• if irregular, heavy vaginal bleeding occurs;

• if tablets are forgotten during the first week of use and sexual intercourse occurred within the preceding 7 days;

• if severe diarrhoea occurs;

• if menstruation does not occur for two consecutive cycles or if pregnancy is suspected (do not start the next pack before consulting a doctor).

3. How to use Marvelon

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

3.1 When and how to take the tablets

The Marvelon pack contains 21 tablets. Each tablet is marked with the day of the week on which it should be taken (see section 6.3 "Explanation of the symbols for the days of the week next to each tablet on the immediate packaging" at the end of this leaflet). Tablets should be taken at the same time each day, with water if necessary.

Take one tablet daily for 21 consecutive days, following the direction of the arrows. Then stop taking tablets for 7 days. A withdrawal bleed (menstrual-like bleeding) is expected during these 7 tablet-free days, usually 2–3 days after taking the last tablet of Marvelon. Start the first tablet of the next pack on the 8th day, even if bleeding has not yet stopped. This ensures that each new pack is started on the same day of the week and that withdrawal bleeding occurs approximately on the same days each month.

Use in children and adolescents

There are no clinical data available on the efficacy and safety of Marvelon in children and adolescents under 18 years of age.

3.2 Starting the first pack of Marvelon

• if the patient has not previously used any hormonal contraceptive method

Begin taking the first tablet of Marvelon on the first day of the menstrual cycle (i.e. the first day of menstruation). There is no need to use an additional contraceptive method.

Alternatively, the first tablet may be taken between day 2 and day 5 of the cycle. However, in this case, an additional contraceptive method (e.g. a mechanical method such as a condom) must be used for the first 7 days of tablet intake in the first cycle.

• if the patient previously used another combined hormonal contraceptive (oral tablets, vaginal ring, or transdermal patch)

You may start taking Marvelon the day after taking the last active tablet of the previous contraceptive (without a break or tablet-free interval). If the current contraceptive includes placebo tablets, start Marvelon the day after taking the last hormone-containing tablet (if in doubt about which tablet this is, consult your doctor or pharmacist). Alternatively, you may start Marvelon later, but no later than the day after the tablet-free interval (or the day after the last placebo tablet) of the current contraceptive.

For users of the vaginal ring or transdermal patch, start Marvelon on the day of removal of the ring or patch, or no later than the day when the next ring or patch would have been inserted or applied.

If the patient has been taking oral contraceptive tablets, a vaginal ring, or a transdermal patch regularly and is certain she is not pregnant, she may discontinue the previous method at any time and immediately start taking Marvelon.

When Marvelon is started according to the above instructions, no additional contraceptive method is required.

• if the patient previously used a progestogen-only pill (so-called "mini-pill")

The mini-pill may be discontinued at any time. Start taking Marvelon the next day at the same time. In addition, use an additional contraceptive method (mechanical method, e.g. condom) for the first 7 days of tablet intake if having sexual intercourse.

• if the patient previously used a progestogen-only injectable, implant, or intrauterine system releasing progestogen

Start taking Marvelon on the day the next injection would have been due, or on the day of removal of the implant or intrauterine system releasing progestogen. In addition, use an additional contraceptive method (mechanical method, e.g. condom) for the first 7 days of tablet intake if having sexual intercourse.

• after childbirth

After delivery, your doctor may advise you to wait until the first menstrual period before starting tablets. Your doctor may also recommend starting earlier. If you are breastfeeding, discuss the use of hormonal contraception with your doctor.

• after miscarriage or abortion

As advised by your doctor.

3.3 Taking more than the recommended dose of Marvelon

No serious harmful effects have been observed after overdose with Marvelon. Taking several tablets at once may cause nausea, vomiting, or vaginal bleeding. If a child accidentally takes Marvelon, consult a doctor immediately.

3.4 What to do if…

Missed dose of Marvelon

• If the delay in taking a tablet is less than 12 hours, contraceptive protection remains effective. Take the missed tablet as soon as possible and continue taking the remaining tablets at the usual time.

• If the delay in taking a tablet is more than 12 hours, contraceptive effectiveness may be reduced. The more tablets missed, the greater the risk of reduced contraceptive efficacy. The risk of pregnancy is higher if a tablet is missed at the beginning or end of the cycle. Please refer to the information below (see also the chart).

More than one tablet missed in a pack

Consult your doctor.

One tablet missed in the first week of use

Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), then continue with the next tablets at the usual time. Use an additional contraceptive method (e.g. condom) for the next 7 days. There is a risk of pregnancy if sexual intercourse occurred in the week before the missed tablet. Consult your doctor.

One tablet missed in the second week of use

Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), then continue with the next tablets at the usual time. Contraceptive effectiveness is maintained, and no additional contraceptive method is needed—provided that all tablets in the preceding 7 days were taken correctly. If this condition was not met, or if more than one tablet was missed, use an additional contraceptive method for the next 7 days.

One tablet missed in the third week of use

There are two options to maintain contraceptive protection without needing an additional method, provided that all tablets in the preceding 7 days were taken correctly. If this condition was not met, the patient should follow the first option below and also use an additional contraceptive method for 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), then continue taking the tablets as usual. Immediately start the next pack the day after the last tablet of the current pack—without a break. Withdrawal bleeding may not occur until the end of the second pack. However, breakthrough bleeding or spotting may occur during tablet intake.

Or

2. Stop taking the remaining tablets in the current pack, take a 7-day or shorter break (including the day the tablet was missed), and then start a new pack. When using this method, you may start the next pack on the same day of the week as usual.

• If a tablet is missed and no withdrawal bleed occurs during the first tablet-free interval, pregnancy should be considered. Consult your doctor before starting the next pack.

yes
week 1 sexual intercourse during the week
preceding the missed tablet
no

• take the missed tablet
• use an additional contraceptive method for 7 days
• finish the pack

Only 1 tablet missed week 2

• take the missed tablet (gap longer
• finish the pack than 12 hours)
• take the missed tablet
• finish the pack
• do not take the 7-day break
• continue with tablets from the next pack week 3 or
• discard the remaining tablets in the pack
• take a break (no longer than 7 days, including the day of the missed tablet)
• continue with tablets from the next pack

In case of gastrointestinal disturbances (e.g. vomiting, severe diarrhoea)
If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a Marvelon tablet,
the absorption of the active substances may be affected. This situation is similar to
missing a tablet; therefore, act as if a tablet has been missed. In case of severe diarrhoea,
consult a doctor.
If intending to change the day on which withdrawal bleeding starts
If tablets are taken as directed, withdrawal bleeding usually occurs approximately
on the same day every 4 weeks. To change this, shorten (but never extend) the next
tablet-free interval. Example: if bleeding usually occurs on Friday, and you wish to
shift it to Tuesday (3 days earlier), start taking tablets from the next pack 3 days earlier
than usual. If the tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding
may not occur during this interval; however, breakthrough bleeding or spotting may occur
during the intake of tablets from the next pack.
In case of unexpected bleeding during tablet intake
During the first few months of taking any oral contraceptive tablets, irregular vaginal
bleeding (spotting or breakthrough bleeding) may occur between withdrawal bleeds.
In such cases, do not stop taking the contraceptive tablets. Such bleeding usually stops
after the adaptation period (usually after 3 cycles). If bleeding persists, is heavy, or recurs,
consult a doctor.
If withdrawal bleeding does not occur
Pregnancy is unlikely if tablets have been taken as directed, no vomiting occurred, and
no other medications have been used. You may continue taking Marvelon tablets.
If withdrawal bleeding does not occur twice consecutively, pregnancy is possible. In this case,
contact your doctor immediately before starting the next pack of Marvelon to rule out pregnancy.
3.5 Discontinuation of Marvelon
You may stop taking Marvelon at any time. If pregnancy is not intended, ask your doctor for
an alternative contraceptive method.
If pregnancy is planned, it is usually recommended to wait until the first natural menstrual period
after stopping the tablets, which facilitates calculation of the expected date of delivery.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Marvelon may cause adverse reactions, although not everyone will experience them. If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Marvelon, medical advice should be sought immediately.

All women using combined hormonal contraceptives have an increased risk of developing venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Marvelon".

Immediate medical attention must be sought if the patient develops symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty in swallowing, or urticaria potentially accompanied by breathing difficulties (see also section 2, "Important information before taking Marvelon").

Common (occurring in more than 1 in 100 women, but less than 1 in 10 women):

• Depressed mood, mood changes
• Headache
• Nausea, abdominal pain
• Breast pain and tenderness
• Weight gain

Uncommon (occurring in more than 1 in 1,000 women, but less than 1 in 100 women):

• Fluid retention
• Decreased libido
• Migraine
• Vomiting
• Diarrhea
• Rash
• Urticaria
• Breast enlargement

Rare (occurring in more than 1 in 10,000 women, but less than 1 in 1,000 women):

• Harmful blood clots in a vein or artery, for example:
  • In the leg or foot (e.g. deep vein thrombosis)
  • In the lungs (e.g. pulmonary embolism)
  • Heart attack
  • Stroke
  • Mini-stroke or transient ischaemic attack (TIA)
  • Blood clots in the liver, stomach/intestines, kidneys or eye

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors increasing the likelihood of blood clots and symptoms of blood clots).

• Hypersensitivity
• Increased libido
• Intolerance to contact lenses
• Skin disorders (nodular erythema, erythema multiforme)
• Galactorrhea (discharge from breast)
• Vaginal discharge
• Weight loss

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Marvelon

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 30 °C. Do not freeze.
Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Do not use this medicine if you notice any colour changes in the tablets, tablet crumbling, or other visible signs of tablet degradation.

6. Contents of the pack and other information
6.1 What Marvelon contains
The active substances are desogestrel 0.15 mg and ethinylestradiol 0.03 mg.
The other ingredients are: colloidal anhydrous silica, lactose monohydrate, potato starch, povidone, stearic acid, RRR-α-tocopherol.

6.2 What Marvelon looks like and contents of the pack
The tablets are round, biconvex, 6 mm in diameter, marked with the code 5 below TR on one side and the word Organon* on the other.
21 tablets – 1 blister strip containing 21 tablets
63 tablets – 3 blister strips containing 21 tablets each
PVC/Al blister in a sachet within a cardboard carton.
A cardboard sachet is included with the pack, into which the blister should be placed.

6.3 Other information
For more detailed information, contact the responsible party or parallel importer.
Responsible party in Portugal, country of export:
Organon Portugal, Sociedade Unipessoal Lda.
Rua Alexandre Herculano, 50 - Piso 9
1250-048 Lisbon
Portugal
Manufacturer:
NV Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Portugal, country of export:
Parallel import authorisation number: 14/20
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
2 F – Monday
3 F – Tuesday
4 F – Wednesday
5 F – Thursday
6 F – Friday
SAB – Saturday
DOM – Sunday